Uli Hack­sell, Cere­cor

Just a few days af­ter Cere­cor was pum­meled $CERC by the news that its lead de­pres­sion drug, CERC-301, failed a mid-stage study, the mi­cro­cap com­pa­ny has been forced to ad­mit that its top drug over­all flopped in a Phase II for nico­tine with­draw­al.

CERC-501, re­cent­ly the sub­ject of some con­sid­er­able mar­ket buzz af­ter a sim­i­lar treat­ment from Alk­er­mes scored pos­i­tive da­ta in two late-stage tri­als, failed the tri­al of 71 heavy smok­ers. But the biotech now plans to sol­dier on in ma­jor de­pres­sion, look­ing to see if it can make progress in a field lit­tered with the corpses of dead drug pro­grams.

Cere­cor’s al­ready bat­tered shares plunged 43%, drop­ping in­to pen­ny stock ter­ri­to­ry in pre-mar­ket trad­ing.

“There is pre­clin­i­cal and re­cent clin­i­cal ev­i­dence that strong­ly sup­port the po­ten­tial use of oth­er KOR an­tag­o­nists as nov­el med­i­cines for the treat­ment of mood- and stress-re­lat­ed con­di­tions, such as MDD and anx­i­ety dis­or­ders. We be­lieve that our KOR an­tag­o­nist, CERC-501, has sim­i­lar po­ten­tial,” added Dr. Uli Hack­sell, Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer at Cere­cor. “We will now turn our fo­cus to prepar­ing CERC-501 for a Phase 2/3 clin­i­cal tri­al as an ad­junc­tive treat­ment of MDD in pa­tients with an in­ad­e­quate re­sponse to stan­dard an­ti­de­pres­sant ther­a­pies. We hope to ini­ti­ate this tri­al in the sec­ond half of 2017.”

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.